Hydrogen Peroxide

Hydrogen Peroxide
SPL v7
SPL
SPL Set ID 45ac0275-4c68-3897-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (3 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-25

Description

Hydrogen Peroxide (stabilized) 3 %

Purpose

First Aid Antiseptic Oral debriding agent


Medication Information

Purpose

First Aid Antiseptic Oral debriding agent

Description

Hydrogen Peroxide (stabilized) 3 %

Uses:

First aid to help prevent the risk of infection in minor cuts, scrapes and burns

Aids in the removal of phlegm, mucus, or other secretions associated with ocassional sore mouth.

Warnings:

For extenal use only.

Directions

First aid antiseptic

Oral debriding agent:

  • Clean the affected area.
  • Apply a small amount of product on the affected area 1 to 3 times a day
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.
  • Mix with an equal amount of water.
  • swish around in the mouth over the affected area for at least 1 minute, and then spit out.
  • Use up to 4 times daily after meals and at bedtime.
  • Children under 12 years of age should be supervised in the use.
  • Children under 2 years of age: consult a dentist, doctor.
Do Not Use:
  • In the eyes or apply over large areas of the body.
  • Longer than 1 week.
Active Ingredient

Hydrogen Peroxide (stabilized) 3 %

Other Information
  • Keep tightly closed and at controlled room temperature.
  • Do not shake bottle.
  • Hold away form face when opening.
Package Labeling:

Inactive Ingredients:

Purified water

Question Or Comments?

Call 956 728-8899

Ask A Doctor Before Use If 

you have deep or puncture wounds, animal bites or serious burns.

Stop Use and Ask A Doctor If
  • The condition persists or gets worse.
  • Sore mouth symptoms do not improve in 7 days
  • Irritation,pain, or redness persists or worsens
  • Swelling, rash, or fever develops.
Keep Out of Reach of Children 

if swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Uses:

First aid to help prevent the risk of infection in minor cuts, scrapes and burns

Aids in the removal of phlegm, mucus, or other secretions associated with ocassional sore mouth.

Purpose

First Aid Antiseptic Oral debriding agent

Warnings:

For extenal use only.

Directions

First aid antiseptic

Oral debriding agent:

  • Clean the affected area.
  • Apply a small amount of product on the affected area 1 to 3 times a day
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.
  • Mix with an equal amount of water.
  • swish around in the mouth over the affected area for at least 1 minute, and then spit out.
  • Use up to 4 times daily after meals and at bedtime.
  • Children under 12 years of age should be supervised in the use.
  • Children under 2 years of age: consult a dentist, doctor.
Do Not Use: (Do not use:)
  • In the eyes or apply over large areas of the body.
  • Longer than 1 week.
Active Ingredient

Hydrogen Peroxide (stabilized) 3 %

Other Information
  • Keep tightly closed and at controlled room temperature.
  • Do not shake bottle.
  • Hold away form face when opening.
Package Labeling:

Inactive Ingredients:

Purified water

Question Or Comments? (Question or comments?)

Call 956 728-8899

Ask A Doctor Before Use If  (Ask a doctor before use if )

you have deep or puncture wounds, animal bites or serious burns.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • The condition persists or gets worse.
  • Sore mouth symptoms do not improve in 7 days
  • Irritation,pain, or redness persists or worsens
  • Swelling, rash, or fever develops.
Keep Out of Reach of Children  (Keep out of reach of Children )

if swallowed, get medical help or contact a poison control center right away.


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Raw Label Data

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